BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 2860011 · Received December 4, 2012

    Report

    Report Number
    1219856-2012-00346
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 3, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WIL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PERFUSIONIST THAT THE EVENT INVOLVED A MALE PATIENT WHILE IN THE OPERATING ROOM (OR) DURING USE. THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED THROUGH THE SHEATH VIA RIGHT FEMORAL ARTERY WITH NO ISSUES. AFTER AN UNKNOWN AMOUNT OF TIME OF THERAPY THE PUMP ALARMED "HIGH PRESSURE" AND AT THAT TIME, BLOOD WAS OBSERVED IN THE HELIUM LINE. AS A RESULT, THE IAB AND SHEATH WERE REMOVED AS ONE UNIT SUCCESSFULLY. A NEW IAB WAS PREPPED AND WAS ABLE TO GET THE FIBEROPTIX SENSOR (FOS) ZERO SUCCESSFULLY. THE IAB WAS INSERTED THROUGH THE SHEATH VIA THE SAME INSERTION SITE (RIGHT FEMORAL ARTERY) WITH NO ISSUES AND THERAPY CONTINUED. THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS A FEW MINUTES DELAY OR INTERRUPTION IN THERAPY WHILE REMOVING AND REPLACING THE IAB WITH NO HARM TO THE PATIENT. THE PATIENT OUTCOME IS OKAY. PER THE PERFUSIONIST THE PATIENT CAME IN NOT DOING GOOD, BUT THIS HAD NOTHING TO DO WITH THE IAB ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. KF2104386

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INTRA-AORTIC BALLOON PUMP